A Study to Evaluate the Safety and Immune Responses to Fluzone® Vaccination
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|ClinicalTrials.gov Identifier: NCT00743275|
Recruitment Status : Completed
First Posted : August 28, 2008
Results First Posted : February 23, 2010
Last Update Posted : May 16, 2016
To describe the safety of the inactivated, split-virion influenza vaccine, 2008-2009 formulation.
To evaluate the compliance, in terms of immunogenicity, of the inactivated, split-virion influenza vaccine 2008-2009 formulation with the requirements of the Committee for Human Medicinal Products (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96.
|Condition or disease||Intervention/treatment||Phase|
|Influenza||Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Immunogenicity and Safety Among Adults of the Inactivated, Split-Virion Influenza Vaccine, Northern Hemisphere 2008-2009 Formulation (Intramuscular Route)|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Experimental: Study Group
Participants received one dose of Fluzone® vaccine on Day 0.
Biological: Split, Inactivated, Trivalent Influenza vaccine (Fluzone®)
0.5 mL, intramuscular
Other Name: Fluzone®
- Number of Participants With at Least 1 Solicited Injection Site Solicited Systemic Reactions Post-vaccination With Fluzone® Vaccine. [ Time Frame: Days 0-3 post-vaccination ]Solicited Injection Site Reaction: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reaction: Fever (temperature), Headache, Malaise, Myalgia, and Shivering
- Geometric Mean Titers (GMTs) for the 3 Influenza Strains Pre- and Post-vaccination With Fluzone® Vaccine 2008-2009 Formulation [ Time Frame: Day 0 and 21 days post-vaccination ]
- Percentage of Participants With at Least 1:40 Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone® Vaccine (Seroprotection) [ Time Frame: 21 days post-vaccination ]Seroprotection was defined as post-vaccination titer value of ≥ 1:40.
- Percentage of Participants With at Least a 4-Fold Rise in Hemagglutination Inhibition Antibody Titer Post-Vaccination With Fluzone Vaccine (Seroconversion) [ Time Frame: 21 days post-vaccination ]Seroconversion was defined as a four-fold rise in titers or greater from baseline. If the baseline titer value is < 10, then 10 is used as the baseline value for the purposes of this calculation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00743275
|United States, Virginia|
|Norfolk, Virginia, United States, 23507|
|Study Director:||Medical Director||Sanofi Pasteur Inc.|